Commercial introducer sets have been developed which are used by doctors in introducing catheters into blood vessels. Such catheters may include a pacemaker lead which is typically introduced into the subclavian vein. Introducer sets include an introducer tool which comprises a sheath that is scored or split at its proximal end to permit splitting thereof longitudinally during the extraction of the introducer tool. Introducers of such construction are disclosed in U.S. Pat. Nos. 4,166,469 and 4,306,562, issued to Philip O. Littleford and Thomas A. Osborne, respectively. During the introduction procedure, a hollow vessel dilator and introducer tool are advanced into the vein over a guide wire. The surgeon obstructs the proximal end of the introducer tool to prevent air aspiration and blood loss when the vessel dilator and guide wire are withdrawn. In those commercial introducer sets having the introducer tool with a split proximal end, it is difficult to obstruct the proximal end because of the unevenness thereof. Further, the introducer tool is sometimes difficult to manipulate because of the floppy condition of the tabs defined by the split in the proximal end.
Some of the commercial introducer tear-away sheaths are formed of TFE Teflon, which has thermal setting properties that make it difficult to reliably and effectively bond other plastic materials to the sheath. However, many surgeons prefer Teflon sheaths because Teflon is so slippery and, in effect, is self-lubricating even though it is difficult to bond a suitable handle to such Teflon sheaths. Other manufacturers form the sheath of polyethylene, which can be remelted and bonded to a handle including knob-type handles. However, polyethylene does not provide the slippery smooth sensation characteristic of Teflon and preferred by a substantial number of doctors.
It is therefore a general object of this invention to provide a novel break-away handle for a tear-away self-lubricating TFE Teflon introducer sheath which enhances the manipulatability of the introducer sheath while providing a positive mechanical connection between the sheath and the handle.
It is another object of this invention to provide a split type, tear-away introducer tool for a catheter introducer set wherein the proximal ends of the introducer tool are provided with a handle which facilitates the manipulation of the tool and other components of the set during the introduction procedure.
Another object of this invention is to provide a split type tear-away introducer tool for a catheter introducer set which has a uniquely constructed handle that serves to stabilize the introducer tool and permits the surgeon to effectively obstruct the proximal end of the tool to thereby minimize the danger of air aspiration and blood loss when the vessel dilator and guide wire are removed.
A further object of this invention is to provide a catheter introducer set with a novel split type tear-away introducer tool having a handle which firmly grips the tabs at the proximal end of the introducer tool and thereby facilitates the tearing of the tool at the completion of the procedure. These and other objects of the invention are defined in the following specification.